This network news story discussed the benefits of the drug varenicline (trade name Chantix) for smoking cessation. Varenicline may be an option for those who have not been able to quit smoking using other drug treatments, such as the anti-depressant bupropion (trade name Zyban) or nicotine replacement therapy. The broadcast provides an incomplete explanation of how this drug differs from nicotine replacement therapy.
The story presents longer-term (1 year) abstinence rates, which are important for evaluating smoking cessation therapies, but it does not compare these numbers to the non-varenicline group. There is also no discussion of side effects. Nausea, headaches, insomnia and other stomach problems were more common in the varenicline group, but none of these are mentioned in the broadcast. More importantly, the story mentions that this drug would be useful for smokers who have high blood pressure or heart conditions; however, varenicline has not been specifically tested in people with these conditions. The clinical trials of varenicline included mainly healthy participants between age 18-65.
Varenicline is currently approved for use up to 12 weeks. Smoking addiction is considered a chronic condition, so the goal of treatment is to prevent relapse. Use of this drug beyond 12 weeks to prevent relapse may be necessary. However, continuing varenicline beyond 12 weeks would be considered an off-label use of the drug. In addition, the broadcast does not mention the current availability or cost of varenicline (which must be taken twice daily). Varenicline is currently not covered by most health insurance plans, so the cost would be out-of-pocket for many consumers.
Approval of varenicline was largely based on two double-blind, randomized studies of 2000 smokers in which the drug was compared with bupropion and a placebo. The studies were both funded by Pfizer, maker of varenicline. The recent studies referred to in this broadcast were also funded by Pfizer, which is not mentioned in the broadcast. (Pfizer is a major advertiser on the evening network news.)
Finally, the story doesn’t discuss the behavioral component of treatment and doesn’t acknowledge that long-term smoking cessation might be accomplished by a number of available therapies, and varenicline is only one option.
The story does not mention the 12-week cost of varenicline (which must be taken twice daily). Varenicline is currently not covered by many health insurers, so the cost would be out-of-pocket for many consumers.
The story provides some quantitative evidence from recent randomized controlled trials of varenicline vs. placebo and varenicline vs. bupropion (although the story doesn’t explain that trial design and never mentions bupropion). The story appropriately notes that abstinence rates at 1 yr. were about half that at 12 weeks. The story did not, however, compare quit rates at one year to the non-varenicline group. Only relative estimates were given, no absolute figures.
No discussion of any side effects of the drug. Nausea, headaches, insomnia and other stomach problems were common in the varenicline groups in clinical trials (about 30% of people), though, this is not mentioned in the broadcast. The story mentions that this drug would be useful for smokers who have high blood pressure or heart conditions; however, the drug has not been specifically tested in people with these conditions. The clinical trials of varenicline included healthy volunteers between age 18-65, with few co-existing health conditions.
The story mentions abstinence rates at 12 and 52 weeks, but does not mention the design of the new varenicline trials. The relative numbers provided here need context: 45-50% of how many patients? What are the absolute rates? Is it 50% of 10 people or 100 people or 1,000 people?
There does not seem to be evidence of disease mongering, however, not all people who attempt to stop smoking will need pharmaceutical treatment.
Approval of varenicline was largely based on two double-blind, randomized studies of 2000 smokers in which the drug was compared with bupropion and a placebo. The studies were both funded by Pfizer, maker of varenicline. The recent studies referred to in this broadcast were also funded by Pfizer, which is not mentioned in the broadcast. (Pfizer is a major advertiser on the evening network news.) Also, the report did not consult independent sources for perspective on this new drug.
This story briefly mentions nicotine replacement therapies. The story doesn’t discuss the behavioral component of treatment or that varenicline was compared with bupropion in clinical trials. When taken once a day, this drug worked nearly as well as bupropion when compared against placebo in randomized controlled studies. There is no acknowledgment in the story that long-term smoking cessation might be accomplished by a number of available therapies, and varenicline is only one option.
Refers to story on recent FDA approval, but doesn’t explain if the drug is available in pharmacies. Many FDA-approved drugs are not on the market yet. And the broadcast does not mention that varenicline is currently approved for only 12 weeks use. The broadcast also does not mention if the drug is available in pharmacies. Smoking addiction is considered a chronic condition, so the goal of treatment is to prevent relapse. Use of this drug beyond 12 weeks (or if relapse occurs) may be necessary to help with continued smoking cessation. Continuing varenicline beyond 12 weeks would be considered off-label use of the drug.
The story is about a nicotine receptor agonist: a new drug with an old mechanism (nicotine replacement). The broadcast does an adequate, but not great job decribing the chemical action of varenicline, a chemical that acts as a mild form of nicotine. This drug differs from nicotine replacement, however. Varenicline binds to the nicotine receptor and only partially activates it so there is less stimulation than by nicotine itself. One of the downstream events from nicotine receptor binding is dopamine release in the parts of the brain wired for reward.
We can’t be sure if the story relied solely or largely on a news release because we can’t be sure who or what the source was for the information. No source is named.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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